This invention relates generally to systems and methods for storing and delivering bioprosthetic heart valves. Systems and methods in accordance with the principles of the present invention may be used for storing and transporting bioprosthetic replacements for any of the heart's valves (e.g., aortic, mitral, pulmonary, and tricuspid). Bioprosthetic replacements such as supra valves may also be stored and transported in accordance with the principles of the present invention. A supra valve may take the place of or supplement the function of the aortic valve, but may be implanted slightly higher in a patient's aorta than an aortic valve. Several disadvantages to current bioprosthetic storage and delivery procedures are addressed by the present invention.
Presently, bioprosthetic heart valves are stored in a solution that must be rinsed off before the valve can be implanted. The valve is suspended in a solution to preserve the tissue of the bioprosthesis. Typically, this solution is either formaldehyde-based or gluteraldehyde-based and care must be exercised in the operating room not to contaminate the sterile operating field with the storage solution.
However, current bioprosthetic heart valve packaging requires the removal of the valve from the storage container before the holder handle may be attached (i.e., the scrub nurse or surgeon may have to reach into the storage solution to retrieve the valve and then remove the structure that was supporting the valve in the jar). Because the jar is completely filled with the storage solution, these cumbersome steps have the potential to contaminate the gloves of the person retrieving the valve. Furthermore, the potential for spilling storage solution in the operating room is high, because the jar is completely filled with storage solution.
The step of rinsing the valve can be problematic in its own right, because this procedure takes at least six minutes. During these six minutes, a scrub nurse must continue to provide the surgeon with instruments, sutures, etc. However, he or she may also be responsible for rinsing the valve. Resting the valve in the rinse basin may damage the valve, and the rinse process may require the rinser to agitate the rinse solution. Thus, the scrub nurse must attend to both the surgeon and the valve rinse procedure. Furthermore, the valve may stay in the final rinse basin for an extended period if the surgeon is not ready for the valve when the final rinse is complete. Finally, some operating room personnel prefer to attach the holder handle to the valve holder while the valve is resting in the sterile field. For these reasons, it may be desirable to provide a device that would protect the valve if it were set down during the operation.
Therefore, it is an object of the present invention to provide a heart valve holder and support assembly that could be allowed to rest in the rinse basin during the rinse procedure without having to worry about damaging the valve. Additionally, it is an object of the present invention to reduce the likelihood of spilling storage solution in the operating room and of contaminating any of the persons or surfaces in the operating room.
A heart valve support and lid liner system directed to these objectives may be implemented with existing heart valve products such as St. Jude Medical's Biocor and Epic heart valve product lines. However, it should be understood that such support and lid liner systems could be adapted to any existing or future heart valve product lines.